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| Name | Class |
|---|---|
| Susan G. Komen Breast Cancer Foundation | OTHER |
| California Breast Cancer Research Program | OTHER |
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The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BreastCARE Intervention | Experimental | Intervention Clinic Patients: The RA will welcome the patient upon arrival at the clinic and again explain study procedures and field any questions. The RA will have the patient sign the HIPAA authorization form and then demonstrate how to enter information and answer questions on the tablet-PC and the patient will indicate their consent electronically before beginning the assessment. Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patietns before she meets with her doctor. |
|
| BreastCARE Comparison | No Intervention | Patients will be randomized into the intervention or comparison groups at the time of recruitment. Block-randomization will be used to assign patients to intervention or comparison groups. Comparison Clinic Patients. Contact and baseline interview procedures will be the same for patients from the comparison clinics, however there will be no computer assessment at the time of their clinic visit. An RA will meet the patient 10 minutes prior to her appointment time to obtain written HIPAA authorization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BreastCARE | Other | Physician Report. At the time of an individual participant's visit to her primary care physician and her completion of the assessment tool, her physician will receive a physician report. The physician report is designed to facilitate communication about breast cancer risk during the primary care visit and to provide tailored risk reduction recommendations. |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge of Breast Cancer Risk Factors | Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O | one week post-initial visit (approximately one week) |
| Percentage of Participants With Correct Perception of Risk | This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age. | baseline, one week post-initial visit (approximately one week) |
| Percentage of Participants Who Had a Discussion of Breast Cancer Risk | Self-reported discussion of breast cancer risk with physicians. | one week post-initial visit (approximately one week) |
| Percentage of Participants Who Reported Discussion of Mammography Screening | Self reported discussion of mammography with physician. | up to 14 months |
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Inclusion Criteria:
Patient component:
Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Celia P Kaplan, DrPH, MA | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital (SFGH) | San Francisco | California | 94110 | United States | ||
| University of California, San Francisco Mt. Zion campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26476466 | Derived | Livaudais-Toman J, Karliner LS, Tice JA, Kerlikowske K, Gregorich S, Perez-Stable EJ, Pasick RJ, Chen A, Quinn J, Kaplan CP. Impact of a primary care based intervention on breast cancer knowledge, risk perception and concern: A randomized, controlled trial. Breast. 2015 Dec;24(6):758-66. doi: 10.1016/j.breast.2015.09.009. Epub 2015 Oct 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care. |
| FG001 | BreastCARE Intervention | Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk. Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor. BreastCARE : The physician will receive a physician report that contains information similar to the patient report. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Number of participants who completed follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care. |
| BG001 | BreastCARE Intervention | Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk. Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor. BreastCARE : The physician will receive a physician report that contains information similar to the patient report. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knowledge of Breast Cancer Risk Factors | Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O | Posted | Mean | Standard Deviation | units on a scale | one week post-initial visit (approximately one week) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Celia P. Kaplan, Professor | University of California, San Francisco | 415-502-5601 | celia.kaplan@ucsf.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| San Francisco |
| California |
| 94143 |
| United States |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percentage of Participants With Correct Perception of Risk | This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age. | Posted | Number | percentage of participants | baseline, one week post-initial visit (approximately one week) |
|
|
|
| Primary | Percentage of Participants Who Had a Discussion of Breast Cancer Risk | Self-reported discussion of breast cancer risk with physicians. | Posted | Number | percentage of participants | one week post-initial visit (approximately one week) |
|
|
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| Primary | Percentage of Participants Who Reported Discussion of Mammography Screening | Self reported discussion of mammography with physician. | Posted | Number | percentage of participants | up to 14 months |
|
|
|
| 0 |
| 655 |
| 0 |
| 655 |
| EG001 | BreastCARE Intervention | Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk. Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor. BreastCARE : The physician will receive a physician report that contains information similar to the patient report. | 0 | 580 | 0 | 580 |
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| D017437 |
| Skin and Connective Tissue Diseases |